Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015701715

FEI Number

3015701715

Entity Name

PERFUZE

City/State/Country

Dangan Galway, IE

Establishment Address

Unit 6 Galway Business Park, Dangan Galway H91 W7CP, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Perfuze (Owner Number: 10086972)

Owner / Operator Contact Address

Unit 6 Galway Business Park, Dangan, IE-G H91 W7CP, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233648

PMA Number

N/A

All Registered Proprietary Names

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Millipede System Millipede 088 Access Catheter Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set Zipline Access Catheter Millipede 088 Access Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2023-11-01
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2026-04-16
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-12-28
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-09-01
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-11-11
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-12-15

Official Correspondent

Anne-Marie Gannon

US Agent Details

Robert Duffy Business: Medical Device Post-Production Services, Inc. Email: Bob.Duffy@mdpps-inc.com Phone: (858) 4871859

Related Public Records

Same Entity

Perfuze

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033736	Concentric Medical, Inc.	MERCI RETRIEVER, MODELS 90065, 90066	2004-08-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

Similar Registrations

Registration Number	Establishment Name	Location
3022392708	INFINITY NEURO, LLC	Lake Forest, CA, US
3014590708	IMPERATIVE CARE INC.	Campbell, CA, US
3014211783	ALEMBIC LLC	Mountain View, CA, US
3008853977	Stryker Neurovascular	Fremont, CA, US
3015615738	Penumbra Inc.	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015701715. Last updated year: 2026. Please use registration number 3015701715 when referencing this establishment in official correspondence.